Contract Component Engineer
Please note that this is a contractor role to be employed through an agency. Medtronic is an equal opportunity employer.
Duties & Responsibilities:
- Define supplier objectives and design requirements, partner with suppliers to ensure components are designed for reliability, manufacturability, and cost reduction via component specifications. Ensure supplier feedback is included in the development process.
- Analyse supplier qualification results, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.
- Drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
- Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause. Assure compliance to procedures and timely completion of CAPAs and audit findings.
- Interpret and implement supply chain related standards and regulations in organizational practices. Ensure compliance to quality system of medical device/combination products development practices. May develop, modify, or maintain quality system procedures owned by the Supplier Quality organization.
- Plan, execute, and communicate own work and educating others on work products. Provide regular, timely communication to manager and project team regarding status of assigned activities. This may include public speaking, publications, and patent applications.
- Performing other related duties as assigned
Qualifications & Experience:
- Typical Minimum Education and Years of Experience: 2 - 4 Years with BSc or Equivalent in engineering, science, or equivalent
- Proficient in word processing, spreadsheets, and managing electronic data files (MS Excel, MS Word, MS Powerpoint, Acrobat Reader, MS Outlook
- Certified Quality Engineer, American Society of Quality or equivalent
- Solid facilitation skills
- Proficient in MS Visio, Documentum, EMatrix, Agile, SAP
- Relevant experience in medical device, pharmaceutical, automotive, aerospace, defense, or other highly regulated industry.
- Experience with new product development
Quality Orientation: Consistently complies with product/service quality standards; contributes to process improvement through the use of quality
tools and measurements; consistently attends to details to ensure accurate, high quality work products.
Innovation: Contributes innovative ideas that lead to positive business results encouraging and adopting new ways of looking at problems, prcesses and solutions.
Customer focus: Meets customer requirements based on an accurate understanding of their needs and expectations; acts on customer feedbackto improve service.
Judgement: Ability to make timely and sound decisions based on thorough consideration of relevant information and the pros and cons of alterntives
Manufacturing Process: advantages/disadvantage of various manufacturing methods for different commodity types, manufacturability, assembly, relation to design specifications, up and down requirements flow, traceability, process control
Engineering Process: design intent, risk management, therapeutic & design functionality, develop qualify & implement controls
Metrology & Measurement; statistical analysis (Cpk, standard deviation, etc), measurement uncertainty, Gauge Repeatability & Reproducibility
Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability
Quality System Knowledge; Interpret and apply relevant regulations and standards for products and processes (IEC, FDA, ISO etc.)
How to Apply
If you feel you meet the necessary requirements for the above role and would like to submit your application, please CLICK HERE.